Cleared Traditional

Aegis Transit System

K170757 · Boston-Biomedical Associates · Ear, Nose, Throat

Jul 2017

Decision

123d

Days

Class 2

Risk

About This 510(k) Submission

K170757 is an FDA 510(k) clearance for the Aegis Transit System, a Mediastinoscope, Surgical (Class II — Special Controls, product code EWY), submitted by Boston-Biomedical Associates (Marlborough, US). The FDA issued a Cleared decision on July 14, 2017, 123 days after receiving the submission on March 13, 2017. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4720.

Submission Details

510(k) Number	K170757 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 13, 2017
Decision Date	July 14, 2017
Days to Decision	123 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	EWY — Mediastinoscope, Surgical
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4720
Definition	If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).